Obesity
Conditions
Keywords
Nutrition, Oxidative Stress, Insulin Resistance, Whole Food Supplement, Pediatric, Retinoids, Antioxidants, Dietary Supplements
Brief summary
Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4), carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity in conjunction with weight management in a cohort of lean as compared to overweight healthy six to ten year-old boys. The boys will undergo a detailed medical and family history and a complete physical examination during the screening visit. Careful anthropometric measures and body composition by DEXA will be performed. Nutritional and exercise counseling will be given at the start of the study. The outcome measures will include differences in serum RBP4, antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months after consumption of FVJC in a randomized double blind placebo control manner.
Interventions
DIETARY_SUPPLEMENTFruit and Vegetable Juice Concentrate (FVJC)
Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
DIETARY_SUPPLEMENTPlacebo
Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
Sponsors
NSA, LLC
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* 6-10 year old healthy boys * Lean or overweight * Have not started puberty
Exclusion criteria
* Chronic illness, asthma, or GI disorder * Vegan Diet * Use of routine medications or vitamins 4 weeks before study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beta-carotene Levels Between Overweight and Lean Boys at Baseline | Baseline | Value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm. |
| Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys | Baseline and 6 months | Value at 6 months minus value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm. |
Countries
United States
Participant flow
Recruitment details
Participants recruited from pediatric endocrinology clinics, in Jacksonville, USA between July 2008 and December 2009.
Pre-assignment details
Of the 246 children screened for eligibility, 74 did not meet criteria, 35 refused to participate, 98 were not randomized for various reasons, 39 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Overweight FVJC Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. | 13 |
| Lean FVJC Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. | 5 |
| Overweight Placebo Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months. | 13 |
| Lean Placebo Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months. | 8 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 3 | 4 |
Baseline characteristics
| Characteristic | Lean FVJC | Overweight Placebo | Overweight FVJC | Lean Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 13 Participants | 13 Participants | 8 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 9.48 years STANDARD_DEVIATION 1.17 | 9.35 years STANDARD_DEVIATION 1.41 | 8.73 years STANDARD_DEVIATION 1.44 | 9.28 years STANDARD_DEVIATION 1.48 | 9.145 years STANDARD_DEVIATION 1.39 |
| Region of Enrollment United States | 5 participants | 13 participants | 13 participants | 8 participants | 39 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 13 Participants | 8 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 5 | 0 / 13 | 0 / 8 |
| serious Total, serious adverse events | 0 / 13 | 0 / 5 | 0 / 13 | 0 / 8 |
Outcome results
Primary
Beta-carotene Levels Between Overweight and Lean Boys at Baseline
Value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overweight | Beta-carotene Levels Between Overweight and Lean Boys at Baseline | 0.22 mM/L |
| Lean | Beta-carotene Levels Between Overweight and Lean Boys at Baseline | 0.29 mM/L |
Primary
Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys
Value at 6 months minus value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.
Time frame: Baseline and 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Overweight | Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys | 334 Percent Change | Standard Error 57 |
| Lean | Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys | 303 Percent Change | Standard Error 85 |
| Overweight Placebo | Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys | -30 Percent Change | Standard Error 57 |
| Lean Placebo | Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys | 23 Percent Change | Standard Error 94 |